Study to Asses Efficacy of Intralymphatic Immunotherapy

Phase 2

Completed

• Conditions: Allergy
• Interventions: Biological: phleum pratense (grass-allergen); Biological: phleum pratense (grass allergen); Other: physiological saline

• Registration Number: NCT01166269
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The purpose of the study is to try a new route for specific immunotherapy (SIT). The current treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50 injections subcutaneously in the upper arm.

The investigators believe that there is additional effect if the allergen is injected directly into the lymph node, since it is here, the allergen presentation is happening. The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).

The investigators would like to see what happens if the the dose is doubled, so the patients will receive 6 injections all in all, with the same amount of allergen as the earlier study (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note their symptoms in a diary.

The patients will be divided into three groups using allocation:

1 group with 6 injections of allergen

1 group with 3 injections of allergen and 3 injections of placebo

1 group with 6 injections of placebo. The trial will be double blinded.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-07
• Last Update Posted: 2012-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• grass pollen allergy through at least 2 seasons
• positive skin prick test
• positive Specific IgE of at least 2. (CAP)
• Signed informed consent
• for females a negative pregnancy test.

Exclusion Criteria

• out of age limits
• rhinoconjunctivitis all year round.
• uncontrolled seasonal asthma
• patients treated with steroids continuously or beta-blockers.
• pregnancy and breastfeeding
• HIV, Hepatitis B+c, and other immunological diseases.
• psychiatric disease
• treatment with SCIT or SLIT within the last 5 years
• participation in other clinical trials within the last 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grass-Allergen x 6	phleum pratense (grass-allergen)	This arm will receive 6 injections of allergen.
grass-allergen x 3 and placebo x 3	phleum pratense (grass allergen)	this arm will receive 3 injections of allergen, and 3 injections of placebo.
placebo x 6	physiological saline	this arm will receive 6 injections of placebo.

Primary Outcome Measures

Name	Time	Method
symptom improvement	2 seasons. (2 years)	The patients will fill out a diary during the grasspollen-season before and after treatment. Also they will fill out a form for the general status of the season passed.

Secondary Outcome Measures

Name	Time	Method
Improvement of reactivity of skin prick test and Specific IgE	2 years

Trial Locations

Locations (1)

Dermato-allergological dept. K; 🇩🇰 Gentofte, Hellerup, Denmark